Devices and methods for skin tightening

ABSTRACT

The methods, procedures, kits, and devices described herein assist with the healing process of tissue that was previously or simultaneously treated for a therapeutic or cosmetic effect. The methods, procedures, kits, and devices described herein can also provide temporary simulated results of a cosmetic procedure to allow for visual assessment to select the type of procedure or for treatment planning in advance of the surgical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/411,443, filed Mar. 2, 2012, which claims benefit under 35 U.S.C.§119(e) to a) U.S. Provisional Application Ser. No. 61/448,809, filed onMar. 3, 2011, b) U.S. Provisional Application Ser. No. 61/476,163, filedon Apr. 15, 2011, and c) U.S. Provisional Application Ser. No.61/605,717, filed on Mar. 1, 2012, all of which are hereby incorporatedby reference in their entirety. This application is also related to U.S.application Ser. No. 11/888,978, filed on Aug. 3, 2007, U.S. applicationSer. No. 12/854,859, filed on Aug. 11, 2010, and U.S. application Ser.No. 13/345,524, filed Jan. 6, 2012, all of which are hereby incorporatedby reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, kits andmethods used for improved healing of skin after a therapeutic injury.For example, such devices, kits and methods can be used to produceimproved tightening of skin after a therapeutic treatment. The devices,kits and methods can also be used to produce a temporary cosmetic effectby displacing skin to stimulate a clinical effect.

BACKGROUND OF THE INVENTION

Many procedures involve producing a therapeutic injury to tissue toproduce an improved therapeutic or cosmetic effect in the tissue. Skintightening is one such therapy that involves creating an injury toproduce an improved cosmetic appearance of the skin near or around thesite of the therapeutic injury. Skin tightening can be performed manydifferent ways ranging from invasive treatments to less invasiveprocedures such as IPL (intense pulsed light). Typically invasiveprocedures appear to be the most effective but require significantrecuperative periods, while less invasive procedures are less effectivethan invasive procedures but the recuperative periods are shorter. Inany case, the healing process that occurs subsequent to the therapeuticinjury can determine the effectiveness of the procedure.

Again, in referring to skin tightening as one example, during theprocedure a physician or medical practitioner induces a controlledtrauma in the skin. This is typically performed by applying energy tothe tissue to either ablate (vaporize) or non-ablatively heat the skinto create either patterns of lesions or a localized area of treatment.There are limits when creating therapeutic injury to tissue, if there isvariability in the lesion or hole created in the tissue the healingprocess may not produce the optimal effect. For example, if thetherapeutic treatment creates openings in the tissue that are too large,the tissue may not heal as desired.

In one variation, a skin treatment system is provided, comprising andressing with a load per millimeter width of at least 0.1 Newtons at astrain of at least 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8,0.9 or higher, and a limiting member coupled to the dressing andconfigured to resist straining of the dressing beyond a predeterminedstrain. The limiting member may comprise a first handle at a first endof the at least one limiting member, and a second handle at a second endof the at least one limiting member. The skin treatment system maycomprise at least two elongate strain limiting structures. The firsthandle may be contiguously or non-contiguously coupled to the dressingbetween the first ends of the at least two elongate strain limitingstructures. The second handle may also be contiguously ornon-contiguously coupled to the dressing between the second ends of theat least two elongate strain limiting structures. The predeterminedstrain may be at least 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08,0.09, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or higher. Thelimiting member may be releasably coupled to the dressing. The limitingmember may be adhered to the dressing using an adhesive. The adhesivemay comprise a shear-resistance to a force level that is greater thanthe T-peel resistance to the force level. The first handle and thesecond handle may comprise a substantially inelastic material relativeto the dressing, which may optionally be a semi-rigid or rigid material.The limiting member may comprise at least one flexible, inelasticelongate element. The dressing may comprise an unstrained configurationin which a distance between a first attachment region of the limitingmember and a second attachment region of the limiting member is lessthan a length of the limiting member between the first attachment regionand the second attachment region, and may comprise a strainedconfiguration at the predetermined strain wherein the distance betweenthe first attachment region of the limiting member and a secondattachment region of the limiting member is substantially equal to the alength of the limiting member between the first attachment region andthe second attachment region. The limiting member may comprise a foldedboard with at least three two folds, or a ratchet and pawl mechanism.The limiting member may be selectively configured to resist straining ofthe dressing beyond a plurality of predetermined strains. The pluralityof predetermined strains may comprise graphical indicia on the limitingmember.

In another variation, the skin treatment system comprises an dressing,comprising a tensioning axis, and a limiting member coupled to thedressing and configured to resist straining of the dressing beyond apredetermined strain, wherein the attachment of a first end of thelimiting member to the dressing is contiguous across a dimension of thedressing transverse to the tensioning axis. The dressing may have a loadper millimeter width of at least 0.1 Newtons at a strain of at least0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.2, 0.3,0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or higher. The limiting member maycomprise a first handle at a first end of the at least one limitingmember, and a second handle at a second end of the at least one limitingmember. The skin treatment system may comprise at least two elongatestrain limiting structures. The first handle may be contiguously coupledto the dressing between the first ends of the at least two elongatestrain limiting structures. The second handle may also be contiguouslycoupled to the dressing between the second ends of the at least twoelongate strain limiting structures. The predetermined strain may be atleast 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, orhigher. The limiting member may be releasably coupled to the dressing.The limiting member may be adhered to the dressing using an adhesive.The adhesive may comprise a shear-resistance to a force level that isgreater than the T-peel resistance to the force level. The first handleand the second handle may comprise a substantially inelastic materialrelative to the dressing, which may optionally be a semi-rigid or rigidmaterial. The limiting member may comprise at least one flexible,inelastic elongate element. The dressing may comprise an unstrainedconfiguration in which a distance between a first attachment region ofthe limiting member and a second attachment region of the limitingmember is less than a length of the limiting member between the firstattachment region and the second attachment region, and may comprise astrained configuration at the predetermined strain wherein the distancebetween the first attachment region of the limiting member and a secondattachment region of the limiting member is substantially equal to the alength of the limiting member between the first attachment region andthe second attachment region. The limiting member may comprise a foldedboard with at least three two folds, or a ratchet and pawl mechanism.The limiting member may be selectively configured to resist straining ofthe dressing beyond a plurality of predetermined strains. The pluralityof predetermined strains may comprise graphical indicia on the limitingmember.

In another variation, a skin treatment system is provided, comprising anelastic structure, first and second handles attached to opposite regionsof the elastic structure, wherein the first and second handles arecoupled to the elastic structure and configured to provide asubstantially uniform tensile force across the elastic structure; and astrain indicator. The strain indicator may comprises graphical ornumerical indicia of the degree of strain.

In one variation, a skin treatment device is provided, comprising afirst layer comprising an elastic material prestretched to apredetermined strain level and a second layer coupled to the first layerand comprising a brace configured to maintain the first layer at thepredetermined strain level while the device is attached to a skin layerof a subject; and comprising at least one second layer openingpositionable for treatment of skin therethrough, and a securing elementconfigured to secure the device to skin of a subject during treatmentthrough said at least one second layer opening. The first layer maycomprise at least one elastic material opening through the elasticmaterial configured to be aligned with the at least one opening of thesecond layer for treatment through the aligned openings. The brace mayfurther comprise a mating element configured to secure the first layerin a strained configuration on the brace. The brace may be rigid. Thebrace may comprise a plurality of segments bendable with respect toanother of the plurality of segments to provide a variable contour ofthe brace. The brace may be configured to be bendable in a plurality ofdirections. Each of the plurality of segments may be configured to bebent in a plurality of directions. The second layer may comprise a maskhaving a pattern of openings. The pattern of openings comprises atreatment pattern. The skin treatment device may further comprise aconnection element configured to connect the device to an energyemitting skin treatment device. Each second layer opening may correspondto at least one individual treatment zone. The second layer may beremovable from the first layer after treatment is provided through theat least one second layer opening.

In another variation, a multilayered elastic dressing is provided,comprising a plurality of elastic layers, wherein each layer removablycoupled to another layer of said plurality of elastic layers; whereinsaid plurality of elastic layers comprises a base layer having a skinadhesive layer on a skin adhesive side of the base layer and at leastone additional layer. Each said at least one additional elastic layermay be removable from the base layer after the dressing has beenstrained and adhered to skin of a subject to thereby selectively alterthe stresses placed on the skin through the base layer.

In another variation, a method of treating a subject is provided,comprising creating a plurality of lesions on a subject's skin andplacing a dressing over the lesions on the subject's skin.

In another variation, a method treating a subject is provided,comprising placing a dressing over a skin region and creating lesions inthe skin region through the dressing. Creating lesions in the skinregions may be performed using an energy-based modality. The dressingmay comprise a mask region configured to selectively block theenergy-based modality and a treatment region configured to selectivelypermit energy from the energy-based modality to pass through thedressing. The treatment region comprises an uninterrupted structureconfigured to selectively permit energy to pass through theuninterrupted structure. The uninterrupted structure may be an opticallyclear structure. The method may further comprise aligning a treatmentdevice to indicia located on the dressing. The method may furthercomprise aligning a treatment device to pre-existing openings in thedressing. The pre-existing openings may be pre-existing potentialopenings in the dressing. The pre-existing potential openings maycomprise slits. The method may further comprise creating a plurality ofopenings in the dressing using a treatment device.

In another variation, a method of treating a subject is provided,comprising maintaining a strain in an elastic dressing, placing thestrained dressing over skin of a subject, creating at least one lesionon the skin of the subject through the dressing; and then releasing thedressing so that compressive forces from the dressing are applied to theskin of the subject.

A need remains for devices, kits and/or procedures to improve theoutcome of such medical procedures by improving the healing process ofthe tissue subsequent to the treatment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A to 1C illustrate the process of a conventional skin tighteningprocedure performed on a section of skin.

FIG. 2A illustrates an example of a wound dressing that assists in thehealing process to improve the outcome of a cosmetic procedure orprovides temporary movement of tissue.

FIGS. 2B to 2D show an example of a dressing assisting in a woundhealing process.

FIGS. 2E to 2G show another example of application of a dressing toassist in the wound healing process.

FIGS. 2H and 2I illustrate an example of a second dressing or frameplaced upon an initial dressing.

FIGS. 3A and 3B respectively show an expanded or strained dressing and adressing in an unstrained or relaxed profile.

FIGS. 3C to 3F show additional variations of dressings.

FIGS. 3G and 3H respectively depicted a dressing with slit openings inan unstrained and strained profile.

FIGS. 3I and 3J depict additional variations of dressings withreinforced openings.

FIGS. 4A and 4B illustrates a dressing and frame respectively, where theframe maintains the dressing in a strained configuration for eventualplacement on tissue.

FIG. 4C shows the dressing of FIG. 4A positioned on the frame of FIG.4B.

FIG. 4D shows a cross sectional view taken along the line 4D-4D of FIG.4C.

FIG. 4E illustrates an optional applicator used to assist in positioningthe dressing of FIG. 4A from a frame to tissue.

FIG. 4F depicts a dressing with reinforced retention openings.

FIGS. 5A to 5C illustrate another variation of a dressing according tothe present disclosure.

FIGS. 6A and 6B shows a dressing having one or more limiting members topre-determine a strain capacity of the dressing.

FIGS. 6C and 6D illustrate a variation of a dressing that incorporates abio-active substance that is intended for delivery to or near the siteof the lesion.

FIGS. 6E and 6F show a variation of a dressing having a varying adhesivepattern on the dressing.

FIGS. 6G and 6H show a dressing that has regions of varying elasticityor stretchability.

FIGS. 6I to 6K show additional variations of dressings that providedirectional or vectored application of force.

FIG. 7A illustrates a contoured shape multi-layer dressing havingregions of varying thickness to allow for customization of a strainamount of the dressing.

FIG. 7B illustrates a further variation of a dressing that includes athermally responsive material.

FIGS. 7C and 7D illustrate various mechanisms for application of adressing.

FIGS. 8A and 8B show a dressing positioned adjacent to treatment devicesthat are used to create lesions within tissue.

FIGS. 9A and 9B show an adjustable frame that permits shaping of theframe to adjust to a contour of a surface of tissue.

FIG. 9C shows a variation of a frame employing an expandable member orbladder to compress tissue within the perimeter of the bladder.

FIG. 9D illustrates another example of an adjustable frame that is usedto compress tissue or expand a dressing.

FIGS. 10A to 10C illustrate a settable adhesive for use with dressingsof the present disclosure.

FIG. 11A illustrates an exemplary plot of power versus time for a lasertreatment application so that a single laser can create an opening in adressing and a subsequent lesion at the site of the opening.

FIGS. 11B to 11E illustrate another variation of using multiple lasersources to create lesions in solid dressing.

FIGS. 12A and 12B shows an example of a dressing having registrationfeatures that allow for detection by the treatment device.

FIGS. 13A to 13E show another variation of a dressing covered by a maskthat directs laser energy to openings within the dressing to controlplacement of lesions.

FIGS. 14A to 14D illustrate various types of lesions that can be createdin situ with a solid dressing.

FIGS. 15A to 15D illustrate another use for dressings of the presentdisclosure.

FIG. 16 depicts an additional use of a dressing as a mask to directcreation of a lesion.

FIGS. 17A and 17B provides a top view to demonstrate compression orapplication of force to a lesion.

FIGS. 18A to 18F show variations of shaped lesions having geometries toprevent high stress areas when compressed.

DETAILED DESCRIPTION OF THE INVENTION

The methods, procedures, kits, and devices described herein are intendedto assist with the healing process of tissue that was previously orsimultaneously treated for a therapeutic or cosmetic effect. Assistingin the healing process can produce an improved outcome and in some casescan eliminate or reduce variability with the healing process. Thecombined therapeutic process of treating tissue and assisting theensuing healing process can produce a consistent skin tighteningprocedure and improve the outcome of the procedure. It is noted thatcombinations of variations of the methods, kits, and/or procedures aswell as combination of specific aspects of methods, kits, and/orprocedures are within the scope of this disclosure even though suchembodiments may not be specifically shown.

U.S. Pat. No. 7,683,234 to Gurtner et al describes devices and methodsintended for the amelioration of scar and/or keloid formation andinclude a discussion of wound healing as well other information that canbe combined with the novel methods, devices, and kits of the presentinvention. Accordingly, the entirety of this reference is incorporatedby reference herein.

The present disclosure describes the methods, procedures, kits, anddevices for use with skin tightening, treatment of skin laxity, skincontraction, skin shrinkage, and maybe even body sculpting proceduresfor purposes of illustration. However, the invention is not limited toskin tightening unless specifically noted otherwise. The benefits of thepresent disclosure can be applied in any number of medical proceduresrequiring providing augmentation of the healing process of a therapeuticor cosmetic treatment. For example, the devices herein may be used forsutureless wound closure, skin splinting or other supportive uses. Otheruses for these skin treatment devices may or may not include withoutlimitation, for example, amelioration or prevention of scar formation,treating skin related conditions such as acne, blemishes, rosacea,warts, rashes (including but not limited to erythematous, macular,papular and/or bullous conditions), psoriasis, skinirritation/sensitivity, allodynia, telangiectasia, port wine stains andother arterio-venous malformations, and ectopic dermatitis; treating orimproving existing scars, wrinkles, stretch marks, loose or sagging skinor other skin irregularities; lifting, pinning, holding, moving skin forvarious purposes such as during pre-operative preparation, duringsurgical procedures for example as a low-profile tissue retractor, tostabilize blood vessels during needle or catheter insertion,postoperatively, pre or post operatively for pre-treating orpreconditioning skin for example, prior to scar revision, woundincision, body contouring, in mastectomy skin expansion, during weightloss, or for aesthetic purposes; hair removal or hair loss; treatingand/or closing skin injuries for example, incisions, wounds, chronicwounds, bed sores, ulcers (including venous stasis ulcers), preventingor reducing the incidence of wound dehiscence, diabetic skin or woundconditions, burn healing and/or relief; acting as an occlusive ornegative-pressure wound dressing; protecting incisions or wounds, e.g.prevention of splitting or opening, protecting newborn belly buttonsafter cutting umbilical cord. Such treatments may include use of a drugor other therapeutic agent that may be applied to the skin with suchdevice. The agents may include but are not limited to antibiotics,anti-fungals, immune modulators including corticosteroids andnon-steroidal immune modulators. The agents may be provided in any of avariety of formulations, including but not limited powders, gels,lotions, creams, pastes, suspensions, etc. The devices may also be usedfor purposes of delivering a drug to the skin or through the skin, forexample by stretching the skin and applying a drug thereto. Differentconfigurations of the device may be amenable to the size or geometry ofdifferent body regions. The treatments may be applied to regions of anyshape (e.g. linear, curved, stellate), size or depth, and to one or moreregions of the body, including but not limited to the scalp, forehead,face (e.g. nose, eyelid, cheeks, lips, chin), ears, neck, shoulder,upper arm, lower arm, palm, dorsum of the hand, fingers, nailbed,axilla, chest, nipple, areola, back, abdomen, inguinal region, buttocks,perineal region, labia, penis, scrotum, thigh, lower leg, plantarsurface of the foot, dorsal surface of the foot, and/or toes.

A number of procedures for tightening of skin are commonly known. Onenon-invasive approach involves the use of laser energy to ablate(vaporize) or non-ablatively heat the skin. Ablative procedures aregenerally more invasive (i.e. longer down time) and effective. Thesetypes of lasers do not produce consistent skin tightening, and presentlynone of these lasers are FDA indicated for skin tightening. In general,the procedure relies on a lesion (if an area is treated) or a number oflesions to heal after the injury to produce a tightened appearance in oraround the skin that was treated. However, if the holes or lesion madeby the treatment device are too large, the skin surface will not healwell. In addition, the procedure might not produce an optimal outcome ifthe healing process is not consistent between the lesions. Furthermore,care must be taken to prevent environmental factors from interferingwith the healing process. Additionally many non-ablative tighteningprocedures rely on collagen contraction to produce volume changes in thecollagen by a thermal denaturation process that produces dimensionalchanges in skin in one or more axes. See, for example, the RF productTHERMAGE® (Solta Corp., Hayward, Calif.) or the IR product TITAN®(Cutera, Inc., Brisbane, Calif.). The devices herein may also be usedwith other skin treatments (aesthetic or not) or resurfacing procedureswhether topical or subdermal, whether or not using an energy modalitysuch as, for example, microwave, radio-frequency ablation,high-intensity focused ultrasound, laser, infrared, incoherent light,thermal (heat and/or cold, ablative or non-ablative), use of vacuum orsuction, vibration or massage (e.g. ENDERMOLOGIE®, LPG Systems, France).The methods, kits, and devices described herein can optionally be usedwith such non-ablative tightening procedures as well. For example, awater jet can be used to create lesions by directing water or otherliquid, and/or a mix of liquid and particles to create the lesions.Furthermore, the water or fluid can be used to swell or expand tissue.Once expanded the tissue can be treated such that upon reversion to anormal non-swelled state, the tissue engages in natural compression.

FIGS. 1A to 1C illustrate the process of a conventional skin tighteningprocedure performed on a section of skin. As illustrated in FIG. 1A, thedermis 10 is located over a region of subcutaneous fat 12. During a skintightening procedure, as shown in FIG. 1B, a physician creates one ormore lesions 14 (i.e., areas of treated tissue or actual openings intissue) in the dermal region 10. The skin tightening procedure relies onthe adjacent healthy tissue to produce a healing response 16 or scartissue that contracts the adjacent regions of the dermis layer 10 asshown by arrows 18. The purpose of the scar tissue 16 is to create astate of traction for the adjacent region of tissue to produce a tissuetightening effect. The single lesion shown in the figures is forillustrative purposes only. Clearly, the number of lesions 14 createdduring the procedure will vary. Moreover, the location of the treatmentdepends upon the particular procedure and region of skin to becosmetically treated.

In conventional skin tightening procedures, there is variability in thehealing phase of the dermis 10. This variability can lessen the desiredcosmetic effect. The dressings described herein are intended to reducethis variability and provide an improved effect as a result of thehealing process. FIG. 2A illustrates one example of a wound dressing 100according to the present disclosure that assists in the healing processto improve the outcome of the procedure. The dressing 100 can have anynumber of shapes as desired by the intended application. For example,the dressing shown in FIG. 2A has a rectangular shape. However,variations include dressings 100 having contoured shapes to accommodateplacement of the dressing around or near various anatomic features.Moreover, the dressing can be cut to fit to a desired anatomic region orto alter the characteristics of the dressing as described below.Alternatively, the dressing can be fit to the desired anatomic regionand cut or shaped after it is placed on the region. Exemplaryconstruction and/or material(s) used for the dressing may include thosedisclosed in U.S. application Ser. No. 12/854,859, filed on Aug. 11,2010, which was alreadyhereby incorporated by reference in its entiretyherein. In some variations, the dressing comprises an elastic materialconfigured with a load per width of at least 0.35 Newtons per mm at anengineering strain of 60% or a load per width of at least 0.25 Newtonsper mm at an engineering strain of 45%. The elastic material may have aload per width of no greater than about 2 Newtons per mm at theengineering strain of about 45% to 60%, about 1 Newtons per mm at theengineering strain of about 45% to 60%, about 0.7 Newtons per mm at theengineering strain of about 45% to 60%, or no greater than about 0.5Newtons per mm at the engineering strain of about 45% to 60%. Theelastic material may have a load per width that does not decrease froman engineering strain of 0% to 60%, a load per width plot that increaseslinearly from an engineering strain of 0% to 60%, or a load per widthplot that is not convex from an engineering strain of 0% to 60%. Theelastic material may comprise an adhesive configured to maintain asubstantially constant stress in the range of 200 kPa to about 500 kPafor at least 8 hours when strained to an engineering strain of about 20%to 30% and attached to a surface. The elastic material may comprise anadhesive configured to maintain a substantially constant stress in therange of 200 kPa to about 400 kPa for at least 8 hours when strained toan engineering strain of about 20% to 30% and attached to a surface. Thesubstantially constant stress may vary by less than 10% over at least 8hours, or by less than 5% over at least 8 hours.

FIG. 2A shows one variation of a dressing 100. In this example, thedressing can comprise an elastomeric dressing (e.g. fabricated fromsilicone) that can optionally stretch as shown in directions 102 toexpand the dressing 100 to an expanded profile 106. The dressing device100 can further optionally include any configuration of adhesive 104 toadhere to skin. The adhesive should not prevent the skin and/or thelesions from compressing as described herein. Alternatively, variationsof dressings can allow for adhesive to be applied prior to or duringapplication of the dressing on tissue.

The device can be placed on the dermis 10 as shown in FIG. 2B. Asdiscussed below, the dressing 100 can be placed on the dermis 10 eitherprior to, during, or subsequent to creation of the lesion 14. Once thelesion 14 is created (or during creation of the lesion 14), the dressing100 applies a closure force F to contract the lesion 14 so that thedressing 100 causes the opening 14 in tissue to close as illustrated inFIG. 2C. The tissue formed 20 as a result of the healing response thenmaintains the dermis 10 in a state of traction even after removal of thedressing 100 as shown in FIG. 2D. The closure force F can be applied ina single direction/axis or in a planar direction (e.g., X-Y axes).Stretching of the dressing 100 can be uniform or non-uniform dependingupon the area of placement. As described below, variations of thedressing 100 can be configured to provide for stretching inpre-determined directions or amounts.

In those variations where the dressing 100 is elastomeric andpre-stretched, the release of the dressing 100 from the stretching forcecreates the closure force F that is applied on tissue. In alternatevariations, the dressing 100 can provide a closure force via thermal,electrical, chemical or other activation of an appropriately configureddressing 100. In such cases, the dressing applies little or no forceunless activated.

As shown above, the dressing 100 can have openings adjacent to thelesion 14. FIG. 3A illustrates these openings 108 in a dressing 100where the dressing is strained or expanded. The openings 108 can bepre-made in the dressing 108 or can be created during the application ofenergy to the tissue. As shown in FIG. 3B, the openings 108 reduce insize or can close when the dressing 100 returns to the compressed orreduced state. The openings 108 can serve an additional purpose ofallowing moisture to pass through the dressing 100. Accordingly,variations of the dressing 100 can include additional openings 108solely allow for passing of moisture through the dressing 100.

The openings may have any of a variety of shapes, including circles,ovals, triangles, square, rectangular, star-shaped, etc. Each of the Insome variations, the openings (or a portion of the openings) maycomprise potential openings which appear to be slits or cuts in thedressing, which then open or spread apart upon tensioning. FIGS. 3G and3H depict one example of a dressing 100 in a unstrained and strainedconfiguration, respectively, with openings 108 comprising slits whichare transversely oriented to the direction of tensioning, which formdouble-tapered openings upon straining. The slits or cuts may be linearor curved, isolated or branching, etc.

In some further variations, one or more of the openings may bereinforced with a thicker or non-elastic material to reduce or controlexcessive strain in the dressing material about the openings, incomparison to regions without openings. In some variations, thereinforcement may comprise open or closed perimeter, ring-likestructures surrounding the openings. Materials that may be used for thereinforcement structures include but are not limited to low-densitypolyethylene (LDPE), fluorinated ethylene propylene (FEP) or nylon. Theopenings 108 of the dressing 100 may comprise individual reinforcementstructures 124, as depicted in FIG. 31, or a regional reinforcementstructure 125 that reinforced multiple openings 108, as depicted in FIG.3J. In other variations, the reinforcement structure may comprise alayer of material embedded or attached to a surface of the dressing, thelayer of material comprising an inelastic material or a material withreduced elasticity relative to the dressing. The layer of material maycomprise identical openings, slits or cuts as the dressing, or may havea different configuration. In still other variations, no openings, cuts,or slits are provided in the dressing, but indicia may be provided onthe dressing to facilitate the formation of a skin lesion patternthrough the dressing. In some variations, the indicia may comprise auniform graphical grid depicted on the dressing, but in othervariations, a non-uniform grid or other non-uniform pattern is provided.

FIGS. 2E to 2G show another variation of application of a dressing 100for use in the methods and devices described herein. In this variation,as shown in FIG. 2E, the tissue is placed under a state of traction oris strained as shown by application of a straining force 18 and thelesions 14 (or a single lesion) are created. Next, as shown in FIG. 2F,a physician positions a dressing 100 adjacent to or on the region oftissue 10 and over the lesions 14. The dressing 100 can have openingsover the site of the lesions 14 or the dressing 100 can be continuous.FIG. 2G shows removal of the strain from the tissue 10 which causesclosure of the lesion 14. Once the strain is removed and the tissuerelaxes is the dressing adhered to the tissue 10. Adhering of thedressing can occur via an adhesive on the dressing, activation of thedressing, or application of an adhesive between the dressing and tissue.

FIGS. 2H and 2I illustrate another aspect of a use of dressings 100 thatcan be combined with the methods and devices described herein. In thisvariation, a dressing 100 is placed upon one or more lesions 14 asdescribed herein. However, a second dressing or frame 101 is positionedto overlap the first dressing 100.

The dressing 100 can be retained on the skin by any number ofmechanisms. For example, some variations include an adhesive locatedbetween the skin and dressing. Alternate variations include the use of atape or other sealing means placed around or at edges of the dressing100. The use of mechanical fasteners, e.g., staples, sutures, etc. isalso within the scope of this disclosures.

FIG. 3C illustrates another variation of a dressing 100 under thepresent disclosure. In this variation, the dressing comprises astretchable layer as discussed above with any number of optional windowor openings 106. Once the dressing 100 is stretched, a frame or brace110 can be applied to the dressing 100 to maintain the dressing 100 inthe stretched configuration. This may be accomplished through afastening system (e.g., clamps or teeth) or via a temporary adhesive.The brace 110 can include any number of windows or openings to providean unobstructed path to the tissue to create the lesions. Once thetreatment occurs, the brace 110 can be removed from the dressing 110 topermit the dressing 100 to compress the lesions. In some variations, thebrace 110 comprises a flexible but inelastic or incompressible materialconfigured to resist a compression load per millimeter width of at leastabout 0.1 Newtons, about 0.2 Newtons, about 0.3 Newtons, about 0.4Newtons, or about 0.5 Newtons, or more. In still other variations, thebrace 110 may comprise a malleable material or a substantiallyinflexible or rigid material. In further variations, in the brace 110may be pre-shaped with a generally planar shape, but in othervariations, may be pre-shaped to a semi-cylindrical or other arcuateshape along one dimension of the brace 110.

FIGS. 3D to 3F show another variation of a dressing 100. In thisvariation, instead of openings, the dressing 114 includes any number ofraised surfaces 114. Prior to application on tissue, this variation ofthe dressing 100 is stretched out, as shown in FIG. 3E. When applied totissue the dressing 100 reverts to its pre-stretched shape so that theraised surfaces 114 separate from the surface of the tissue as shown inFIG. 3F. In such a variation, adhesive can be applied to the planarportion of the dressing 100 around the raised areas 114.

Any of the dressings 100 shown above (and/or braces) can be mated oraligned with the lesion-creating device so that the dressing can beapplied with a single device. Alternatively, a number of dressings 100can be fitted to the treatment device in a cartridge-like form so thatthe physician can position a dressing onto the treatment device prior toapplication of the device to tissue.

FIG. 4A illustrates another variation of a dressing 100 for use asdescribed herein. In this variation, the dressing 100 includes anynumber of openings 108 that allow for creation of the lesions. Inadditional variations, the dressing 100 may not have any lesion-openings108. In such a case, the treatment could take place through the dressing100 or the openings 108 could be created after the treatment. In anycase, this dressing variation includes one or more retention openings109. The retention openings 109 are designed so that the dressing can bestretched over a mask or brace 110 as shown in FIG. 4B. The brace 110will include a number of mating retention tabs 116 so that the dressingcan be stretched across the brace 110 and retained on the tabs 116. Inthis variation, the brace 110 includes a single central opening 118.However, as described above, the brace 110 can include any number ofopenings (i.e., to match the openings on the dressing, or to providestructural rigidity to allow for stretching.) Typically, the brace 110is stiff or inflexible when compared to the dressing 100. However,variations can include a brace 110 that is stiff when compared to thedressing 100 but is malleable so that the brace can conform to thecontours of a targeted region of tissue. As mentioned previously, thelesion-openings 108 (or other drainage or access openings of thedressing) may be individually reinforced or regionally reinforced toreduce or control any relative greater strain that may occur in regionswith openings 108 in comparison to regions of the dressing 100 withoutopening. As depicted in FIG. 4F, the retention openings 109 of thedressing 100 may also be reinforced with a reinforcement structure 126,which may facilitate manual stretching and attachment of the dressing100 to the brace 110 by the user. Reinforcement of the retentionopenings 109 may be beneficial reducing excessive straining of thedressing region 127 between the retention opening 109 and the closestadjacent edge 128 of the dressing 100.

FIG. 4C illustrates the dressing 110 stretched across the brace 110 withthe retention tabs 116 inserted into the retention openings 109 of thedressing 100. FIG. 4D illustrates a cross sectional view taken along theline 4D-4D from FIG. 4C. To release the dressing 100 from the brace 110,the ends of the dressing 100 can be pulled away from the brace when thedressing engages tissue. As discussed herein, the dressing 100 caninclude an adhesive to secure the dressing onto tissue. Alternatively,an adhesive or other fastening means can be applied to the dressing whenthe physician places the dressing on tissue. FIG. 4E illustrates avariation of a dressing 100 located on a frame 116 with an applicatorthat can be used to secure the dressing 100 against tissue as thedressing 100 is released from the retention tabs 116.

FIGS. 5A to 5C illustrate another variation of a dressing 100 accordingto the present disclosure. In this variation, the dressing can beconfigured to provide a uni-axial compression (compression along oneaxis) where required or a unidirectional compression (i.e., movement ofthe dressing occurs in a pre-determined direction). FIG. 5A shows aseries of lesions 16 created on a face 1 of a patient. In this example,the therapeutic procedure creates the lesions 16 in a line array typepattern as opposed to a plurality of points or dots, where the lines oflesions 16 are arranged or aligned in a pre-determined direction. Forexample, the pattern can be made in alignment with, against, and/ororthogonal to Langer's lines, also referred to as cleavage lines.Langer's lines are topological lines drawn on a map of the human body.These lines correspond to the natural orientation of collagen fibers inthe dermis and epidermis and can be defined by the direction in whichthe skin of a human cadaver splits when struck with a sharp point. Inpractice, a series of dressing can be applied with differingorientations corresponding to typical or mapped Langer's Lines.

For example, the physician can create lesions aligned to a directionalpath that is similar to sutures that could be used to tighten thetissue. FIG. 5B illustrates a dressing 100 stretched in direction 102and having a plurality of openings 108 that open along the stretcheddirection. As discussed above, the dressing 100 can include an adhesivefor securing to tissue. Alternatively, the adhesive can be appliedbetween the skin and dressing or another mode of fixation can beemployed. FIG. 5C shows the dressing 100 upon reaching a pre-stretchedor relaxed state. As shown, the openings 108 reduce in thickness tocompress the lesions when forming the tissue 20 generated as a result ofthe healing process.

In another variation, a dressing 100 can be adhered to tissue or skinwithout significantly stretching and then is stretched. Stretching thetissue in this manner uniformly and gently stretches the skin underlyingthe dressing in a direction along Langer's lines along with thedressing.

When the skin is then treated through the dressing in a stretchedcondition, releasing the stretch as well as removing the dressing willallow a gentle closure force due to the skin's own natural elasticity.Presently, physicians stretch tissue using their fingers to stretch thetissue area as they treat. However, this process increases overallprocedure time since the physician is only able to treat small areas atany given time. A variation of present invention includes a dressingthat is stretched after being applied to the skin to stretch the skinalong Langer's lines. Once the tissue is treated, the dressing isremoved. This permits the natural resiliency of the skin to provide agentle closure force without having to leave the dressing in place.

FIGS. 6A and 6B illustrate an aspect of dressings 100 described herein.In this example, the dressing 100 includes one or more limiting members122 to pre-determine a strain capacity of the dressing 100. For example,as shown in FIG. 6A, the limiting members 122 are shown in a compressedconfiguration. When the dressing is stretched, as shown in FIG. 6B, thelimiting members 122 approach their predetermined length to limit themaximum strain of the dressing 100. Accordingly, a physician can beprovided with a number of dressings 100 each having a varying amount ofmaximum strain. Although FIGS. 6A and 6B illustrate a dressing havinguni-directional strain or deflection, variations of the inventioncontemplate limiting members that limit strain in a bi-axial direction.The limiting members 122 can be comprised of a shape memory alloy suchas a super-elastic alloy or a heat activated alloy that extends orcontracts in response to a temperature shift. Although a zig-zag shapeis depicted for the limiting member 122 in FIG. 6A, in other variations,the limiting member may comprise an undulating configuration or othercurved configuration, or any non-linear configuration. The limitingmember may comprise any of a variety of relaxed threads, strings, wiresor other elongate, elongatable, straightenable or stretchable membersthat straighten, lengthen and/or stretch to a desired amount, degree,and/or preset limit. The limiting members may be configured with asufficient tensile strength to prevent, resist or otherwise controlover-stretching of the dressing. The skin treatment device may beconstructed of multiple layers of an elastic material such as siliconewith an adhesive between layers to which the members are attachedinitially in the relaxed, undulating, sinusoidal, unstraightened orother unstretched configuration. According to a variation, the shapelimiting strings or other devices may prevent straining in regions wherestraining or less strain is desired. For example, the threads may bestraight at the edges of the skin treatment device to prevent strainingat the edges. In some variations with multiple limiting members, thelimiting members may be equally spaced apart and have uniform lengthsand uniform attachment points across a transverse dimension to thetensioning axis of the dressing. In other variations, the limitingmembers may have a variable or non-uniform spacing, may have non-uniformlengths, non-uniform attachment points, and may also be seriallyarranged along the tensioning axis. The opposing ends of the limitingmembers 122 may also optionally have removable (or non-removable)manipulation elements 123 attached to the ends to provide for a moreeven or uniform strain, and may comprise an inelastic material which isthe same or different as the limiting members 122. The manipulationelements 123 may span the entire transverse dimension of the device 100to the axis of tensioning, as depicted in FIGS. 6A and 6B, but in othervariations may be less than the entire transverse dimension (e.g. havinga transverse dimension sufficient to span a plurality of limiting member122, but less than the full transverse dimension of the dressing 100.Such elements may comprise planar members, handle members, flexiblemembers and/or inflexible members. They may be attached and removed in avariety of manners, for example as described herein.

FIG. 6C illustrates another variation of a dressing 100 thatincorporates a bio-active substance that is intended for delivery to ornear the site of the lesion. In one example, the dressing 100 includes apolymer layer (e.g., silicone) and an adhesive layer 184. The dressing100 can also include a bio-active substance 182. Although the bio-activesubstance is shown as a separate layer 182, variations of the dressingscan include a bio-active substance that is infused with the polymerlayer 180 and/or adhesive layer 184. Alternatively, the bio-activesubstance can be a separate layer. FIG. 6D illustrates the dressing 100of FIG. 6C after an opening 108 is made in the dressing 100 duringcreation of a lesion 14. As shown, creation of the opening causes thebio-active substance to enter the lesion 14 as represented by arrows186. The bioactive substance can be an activated substance, such as aRose Bengal dye (a photosensitive dye typically used to cross-linkcollagen and is activated by light having wavelengths of 514 nm, 532 nmor 458 nm). Alternatively, the bioactive substance can be any drug orpharmaceutical substance delivered for a particular effect on the lesionor tissue. In further examples, the substance can be a material thatcauses cross-linking of collagen, such as riboflavin and/or glucose.Examples of other bio-active agents that may be used include hemostaticor coagulative agents to help reduce bleeding. Such agents includechitosan, calcium-loaded zeolite, microfibrillar collagen, cellulose,anhydrous aluminum sulfate, silver nitrate, potassium alum, titaniumoxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X,XIII, Von Willebrand factor), procoagulants (e.g. propyl gallate),antifibrinolytics (e.g. epsilon aminocaproic acid), and the like. Insome variations, the agents may be freeze-dried and integrated into thedressing and activated upon contact with blood or other fluid. In somefurther variations, an activating agent may be applied to the dressingor the treatment site before the dressing is used on the subject. Instill other examples, the hemostatic agent may be applied separately anddirectly to the wound before application of the dressing, or afterapplication to the dressing via a catheter or tube. The devices may alsocomprise one or more other active agents that may be useful in aiding insome aspect of the wound healing process. For example, the active agentmay be a pharmaceutical compound, a protein (e.g., a growth factor), avitamin (e.g., vitamin E), or combinations thereof. A further example ofsuch medicament may include, but is not limited to various antibiotics(including but not limited to cephalosporins, bactitracin, polyxyxin Bsulfate, neomycin, polysporin), antiseptics (such as iodine solutions,silver sulfadiazine, chlorhexidine), antifungals (such as nystatin),antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus,paclitaxel), grow factors (such as VEGF) and other treatments (e.g.botulism toxin. Of course, the devices may comprise more than onemedicament or agent, and the devices may deliver one or more medicamentsor agents.

FIGS. 6E and 6F show another variation of a dressing 100 having anadhesive pattern 104 that varies on the dressing 100 as opposed to beinglocated on the entire surface of the dressing 100. FIG. 6E shows oneexample of a varying adhesive pattern 104 where the adhesive layersalternate with uncovered sections 107. When applied to tissue 10 andreleased from the strained condition, the dressing 100 contracts at theuncovered regions 107 causing the tissue 10 to buckle at the uncoveredregions 107 as shown in FIG. 6F. Other examples of variable adhesivepatterns on the dressing are described in U.S. Pub. No. 2011/0152738,filed on Aug. 11, 2010, which was already incorporated by reference inits entirety herein.

FIG. 6G shows another variation of a dressing 100 for use as describedherein. In this variation, the dressing comprises a varying elasticityacross different sections. For example, as shown, a dressing can have anelastic section 126 coupled to a relatively less-elastic section 127.The illustrated variation shows the elastic section 126 as being thinnerthan the less-elastic section 127. However, any number of configurationscan provide varying stretch or elasticity. For example, the differentsections can have different reinforcements, different materials withvarying durometers. One such use of the varying dressing 100 is shown inFIG. 6H, which shows the less elastic section 127 placed in an areawhere stretching of the skin is not desired and the elastic section 126being used to produce a pulling force in a desired direction as shown byarrows 128. Other examples of dressings with variable elasticity regionsare described in U.S. Pub. No. 2011/0152738, which was alreadyincorporated by reference in its entirety herein. In one particularexample, a dressings may be tapered near its edges to reduce thickness.A tapered edge may also ameliorate peak tensile forces acting on skintissue adjacent to the adhesive edges of the dressing. This may or maynot reduce the risk of skin blistering or other tension-related skintrauma. In other variations, the edges of the dressing may be thickerthan the middle of the dressing. It is hypothesized that in someconfigurations, a thicker dressing edge may provide a relative inwardshift of the location of the peak tensile forces acting near thedressing edge, compared to dressings of uniform thickness.

FIGS. 6I to 6K show additional variations of dressings 100 that providedirectional or vectored application of force. As shown, the dressings100 can include adhesive 104 such that when applied to tissue thedressing is pulled to provide a strain in tissue in a desired direction.Benefits of such a variation include providing the physician withcontrol over the degree of strain. Furthermore, the dressings can betreated with, for example, a chromophore to monitor the degree of strainin the dressing. Other examples of a color change material or structurethat may be used or incorporated into the dressing are described in U.S.Pub. No. 2006/0246802 to Hughes et al, which is herein incorporated byreference in its entirety.

FIG. 7A illustrates another variation of a dressing 130 that includes acontoured shape for suited for placement on specific anatomy (forexample, the illustrated dressing 130 can be placed on a face of apatient having a larger area at a lower region to accommodate placementalong the jaw-line and a smaller surface area at a top region toaccommodate placement close to the ear). FIG. 7A also illustrates thedressing 130 as having a varying thickness across the length of thedressing 130. The varying thickness allows for a physician to adjust theamount of strain that the dressing 130 applies to tissue. For example,section 132 can include the greatest number of layers, which translatesinto the highest strain rate. To reduce the strain rate, the physicianor medical practitioner would cut or remove section 132 from thedressing 130. Removing section 132 leaves sections having fewer layersand as a result, lower strain rates. Although the figure illustratesthree sections 132, 134, 136, any number of sections is within the scopeof this disclosure.

FIG. 7B illustrates a further variation of a dressing 100 that includesa thermally responsive material. In this variation the dressing 100 caninclude one or more openings 108 but the construction of the dressing100 allows for customization of the location as well as degree of strainthat the dressing 100 will apply on tissue. The dressing can be adjustedusing visible or UV light, or it can be activated using a chemicalresponse or via heat. The dressing can also include a separate layerthat drives shrinkage of the dressing upon activation (e.g., via alaser, heat, other irradiation). In any case, use of a shrinkabledressing permits customization to create tension or strain in a desireddirection during the treatment procedure.

FIGS. 7C and 7D illustrate another mechanism for application of adressing 100. As shown, a dressing 100 can be applied using a rollerapplicator 160. The roller applicator 160 can strain the dressing 100 asit applies the dressing 100 to tissue 10 over the lesions 14.Alternatively, the roller applicator 160 can apply a pre-straineddressing 100 that compresses tissue 10 and the lesions 14 uponpositioning on the tissue 10. FIG. 7D illustrates a roller applicator160 that is coupled to a lesion creating device 146, which creates thelesion 14 and where movement of the device 146 causes the roller 160 toapply the dressing 100. The device 146 can also include one or moresensors 148 to provide feedback of location to the system or can be usedto detect movement of the device 146. In some variations, the rollerapplicator 160 may comprise a ribbon spring (or other spring mechanismor tension control mechanism) to resist rotation of the roller until aspecific tension threshold is achieved.

FIG. 8A shows another application of a dressing 100 as described herein.In this variation, the dressing 100 is coupled to a treatment device140. The treatment device 140 can create a lesion through any variety oftreatment modes where the active elements 142 of the treatment memberspass through openings in the dressing. For example, the treatment device140 can create the therapeutic lesion using RF energy, plasma, cryogenicenergy, microwave energy, laser, optical energy (non-laser) chemical,resistive heat, ultrasound energy, or via mechanical energy. As shown, adressing 100 can be coupled to the treatment device 140 so that aftercreation of the lesions, the treatment device 140 can be removed leavingthe dressing in place to apply compression to the lesions.Alternatively, the treatment device 140 can be directly applied over adressing 100 that was previously positioned. In some variations, thedressing 100 may comprise a pattern of treatment openings withpredetermined size, spacing or location, and the treatment device 140may comprise a matched pattern or array of treatment elements 142 withthe same spacing or location. In some variations, the pattern oftreatment openings in the dressing 100 may comprise a repeatingsub-pattern, and the treatment device 140 may comprise a matched patternor array of treatment elements 142 to the dressing subpattern ofopenings. In these variations, the dressing 100 may comprise indicia todelineate the locations of the subpatterns. Thus, the treatment device140 may be used at multiple regions of the dressing 100. The pattern orarray of treatment elements 142 of the device 140 may comprise at least2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 treatment elements.

FIG. 8B illustrates another variation of a dressing 100 in combinationwith a treatment device 144. In this variation, the treatment device 144creates openings within the dressing 100 before or during the actualtreatment. For example, the treatment device can employ a laser,optical/light, chemical, ultrasound or electrical energy to create anopening through the dressing while creating the therapeutic lesion intissue beneath the dressing. Moreover, device 144 can apply energy to adressing 100 to activate the dressing 100 induce or adjust strain. Insuch a case, the dressing can be in an unstrained condition prior toactivation by the device 144. Alternatively, or in combination, thedevice 144 can reduce or increase a strain in the dressing dependingupon the desired application. FIG. 8B illustrates lesion creatingelements 145 positioned adjacent to the dressing 100. In the event thatthe device 144 employs a laser to create lesions, the laser is emittedfrom the elements 145 and can either pass through the dressing 100 orcan create openings in the dressing. In those variations where thelesion creating elements 145 comprise electrodes or mechanical members,the elements 145 can pass through the dressing when advanced from thedevice 144.

In many cases, the dressings described herein are intended forpositioning on contoured tissue surfaces rather than planar surface.Accordingly, there may be a need to provide a dressing that canapproximate the contoured shape prior to affixing to the tissue surface.FIGS. 9A and 9B show one possible solution to adjust a contour of adressing described herein. FIG. 9A shows a variation of an adjustableframe 150. In this example, the frame 150 includes a plurality ofadjustable links 154 coupled between two end-pieces 152. However,variations of the frame 150 include adjustable links 154 forming theentire periphery of the frame. As discussed above, the frame 150 caninclude one or more fixtures to permit retention of the dressing. FIG.9B illustrates the adjustable frame 150 where one or more of theplurality of links 154 can be adjusted or extended to permit a portionor all of the frame 150 to form a contoured shape. Although notillustrated, a dressing attached to the frame 150 will then be in abetter configuration when being secured to a contoured tissue surface.

In additional variations, a frame can be used without a dressing toapply strain to the tissue in a similar manner as a dressing. Forexample, a deformable frame can apply a compression force to the tissueand then can be affixed to the tissue in a manner as described herein(e.g., adhesive, mechanical fasteners, sutures, etc.) Doing so allowsthe frame itself to compress tissue to assist healing of the treatedregion.

FIG. 9C shows another variation of a frame 156. In this variation, theframe 156 employs an expandable member or bladder 158. When affixed totissue the bladder can be inflated or expanded to position 160 toprovide compression within the area bounded by the frame 156 and bladder158. In other variations, a foam (open cell or closed cell) may beprovide within the bladder to maintain the bladder in an expanded state,and negative pressure may be applied to reduce the bladder/foam size. Instill other variations, the frame may comprise a foam member in lieu ofa bladder member to provide a resilient or contouring surface orstructure for the frame.

FIG. 9D illustrates another example of an adjustable frame that is usedto compress tissue. In this example, the frame 170 can have hinges orjoints 176 that transmit a force 172 applied at the joints to result inan expansion force 174 at the edges of the frame. In some variations,the frame is biased to return to its initial shape upon application of aforce. In such a case, after force 172 is applied to the frame, theframe 170 provides compression within the area bounded by the perimeterof the frame 170. In use, a physician could apply the activation force172 to the frame, then adhere portions of the frame 170 to tissue. Asthe frame 170 attempts to return to its initial shape, the return forcecompresses tissue within the frame. In an alternate variation, the frame170 is not biased. Instead, the frame 170 can be affixed to an elasticdressing (not shown) as described above. In this example, application offorce 172 causes expansion or straining of the elastic dressing indirection 174. A physician or medical practitioner can then affix thestrained dressing 170 to tissue where the resiliency of the tissuecompresses the tissue.

The dressings of the present invention can also provide temporaryresults to simulate a clinical effect. These temporary results can allowa patient or physician to determine the type or amount of treatmentdesired. For example, a physician can position pre-strained dressings ona patient to show the patient the results of a procedure given apre-determined amount of shrinkage or lift. Such a feature allows aphysician to position dressings having a pre-determined amount of strainon a patient so that the patient can visually see the results of thegiven reduction. For example, a physician can position dressings thatlift the skin by a given amount so that the patient can determinewhether more or less lift is desired. The goal is to simulate clinicalresults and allow a patient to see a real time simulated clinical resultvia the application of the dressings. Such pre-strained dressings can beprovided as a kit having varying ranges of displacement withcorresponding templates to assist the physician in applying applytherapeutic treatments to match the temporary state of the tissue. Inthis way, a patient can observe the simulated clinical result, once adesired result is achieved; the physician can select treatment templatesbased on the dressings that are used to produce the temporary effect.Use of the dressings to simulate a clinical effect can be used in anynumber of cosmetic procedures outside of skin tightening. In additionalvariations, the simulated clinical effect can be used to establish atreatment plan. Such a treatment plan can include the amount of orlocation where the therapeutic treatment. The simulated clinical effectcan be processed through a computer analysis to provide the physicianwith a treatment plan based on the type of dressing used or amount oflift used to produce acceptable or desired results.

FIGS. 10A to 10C illustrate another aspect for use with dressings of thepresent invention. As shown in FIG. 10A, a dressing 100 that is placedover a lesion 14 when used to apply compression to the dermal layer 10of skin. In this variation, the dressing 100 includes an adhesive layer104. In some variations, the adhesive layer 104 is sufficient to preventcreeping or movement of the tissue 10 subsequent to placement of thedressing 100. However, in certain circumstances, as shown in FIG. 10B,the tissue 10 contacting the adhesive layer 104 can begin to creepcausing the lesion to move in the direction shown by arrows 162resulting in opening of the lesion 14. The creep of the tissue 10 canoccur due to the restoring force of the skin, which may be higher in aparticular target location. Alternatively, creeping of tissue can occurdue to the thickness of the elastic layer or when the adhesive layer isnon-rigid and/or deformable and takes time to secure the dressing to thetissue.

FIG. 10C provides a representation of an alternate variation of adressing 100 having an adhesive material 105 that can be activated orset. In some variations the settable adhesive material 105 is set from aliquid or viscous phase to a solid phase via UV or IR irradiation oreven oxidative curing. In some variations, use of oxidative curingallows for securing of the dressing without heating of the tissue and/ordressing. As shown in FIG. 10C, the adhesive material 105 solidifies tokeep the lesion closed but also remains pliable to allow the dressing100 to remain pliable and conform to the curvature of the tissue.

In additional variations a dressing can be used to limit the lesion sizeor to minimize collateral damage to tissue. For example, a soliddressing can be applied to tissue as described above. Next, a laser canthen be used to create openings in the dressing as well as to create thelesion. For instance, an Er:YAG laser or an Er:YsGG may be used with aCr2+:or CR2t:ZnSe Q-switching device, or a Cr2+:Cr2t:ZnS Q-switchingdevice to apply a pulse in a Q switched mode followed by a free runningmode or normal mode. The pulse could be used to remove a portion of thedressing since the pulse produces a plasma initiation and expansion tophotomechanically remove the layer of the dressing (e.g., a siliconelayer). The free running mode operation creates a micro lesion viaphotothermal ablation of the tissue.

FIG. 11A illustrates an exemplary plot of power versus time for a lasertreatment application so that a single laser can create an opening in adressing and a subsequent lesion at the site of the opening. As shown,the first applied pulse 166 reaches a power level much greater than thatof the subsequent free running mode pulse 168. One benefit of creatingopenings in the dressing simultaneously or immediately prior to creatingthe lesions is to eliminate alignment of the openings and lesions.

FIGS. 11B and 11C illustrate another variation of using a solid dressingand creating openings in the dressing once the dressing contacts thetissue. As illustrated in FIG. 11C, the treatment can include two oremore different types of lasers 174, 176, where one of the lasers 174 canbe selected such that it is highly absorbed by the dressing 10. Whilethe second laser 176 can be selected such that it is highly absorbed intissue. For example, a CO2 and Er:YAG laser can be used together. Thewavelength of the CO2 laser is highly absorbed by silicone and thewavelength of the Er:YAG laser is highly absorbed in skin. In oneexample, the wavelength required to create openings in the dressing is10.6 μm while the wavelength for creating lesions could range from 1.9to 3.3 μm. The lasers can be arranged so that they are either co-axialor confocal (e.g., the laser elements if FIG. 11C can be rotated ormoved so that each laser targets the same region.) Alternatively, thelasers can be configured to deliver light in a concentric manner. Inuse, the lasers are time-delayed as shown in FIG. 11B, which illustratesa graph of power versus time. As shown, the first laser 174 delivers afirst pulse 170 to create the opening in the dressing 10. The pulse 172from the second laser 176 can be staggered or delayed to allow forejection and/or removal of debris. While any variation of lasers can beused in this configuration, one desirable variation can include the useof two low power lasers to provide each source of light. Alternatively,a more complicated dual wavelength system can be used. Such a systemcould deliver multiple wavelengths of light as described above.

FIG. 11D shows the system of FIG. 11C, where the first laser 174 createsan opening 108 in the dressing 100 but not the skin since the laser isnot absorbed by the skin. FIG. 11E shows the second laser 174 creatingthe lesion 14 through the previously created opening 14.

The above system or configuration allows for a skin tightening therapywith an adhesive patch applied to skin with the skin and patch ablatedin situ. The patch is applied to untreated skin under tension with anadhesive. The patch initially does not have holes over the areas wherelesions are to be formed. The entire patch may be solid or may haveholes or other features to position and/or stretch the patch. An initiallaser beam ablates holes or other features in the patch to exposecertain areas of the skin. The exposed areas can then be treated throughholes in the patch. The laser parameters are such that the patchmaterial is cleanly ablated with a minimum of thermal damage to theunderlying skin. A second laser beam of possibly different character isthen used to ablate a controlled amount of skin. An additional benefitof creating openings in the dressing and subsequently creating lesionsis that the lesion pattern and/or openings in the dressing can becustomized during a procedure rather than needing to follow the patternof a pre-configured dressing.

One benefit of creating openings in the dressing in situ is that thereis no need for orienting a dressing having pre-made openings withpreviously created lesions. Yet another benefit of creating openingsin-situ is that the pattern or features of the holes in the dressing arecustomized to match the lesions.

FIG. 12A shows an example of a dressing 100 having one or moreregistration features 202, 204 allowing for detection and/or recognitionregarding characteristics of the dressing. For example, FIG. 12A showsregistration features 202 and 204, which allow for optical scanning orreflecting light that can be used to confirm alignment of the treatmentdevice. Alternatively, or in combination, the presence or relativeposition of the registration features 202 and 204 can provide any rangeof information regarding the pattern of openings 108 or even thelocation where treatment should occur. For example, in FIG. 12A, lesionsare created in the openings that are within specific registrationfeatures 202 and 204.

Once the system obtains feedback regarding the registration features,the system can confirm that the treatment device is in the correctposition. Subsequently, image analysis hardware and software can be usedto recognize the patterns or openings 108 in the dressing 100 to eithercontrol the treatment parameters, to maintain a database of treatmentareas, or to perform some other custom treatment depending upon type ofdressing or orientation of the dressing.

One approach is to position a handheld scanning handpiece directed atthe approximate location of the treatment. The system can determinewhether positioning of the handpiece is within an acceptable toleranceusing an optical detection of one or more registration features 202,204. Once the system confirms correct or acceptable positioning, thesystem can then permit or trigger a treatment cycle. For example, alaser scan pattern can be released on a time scale sufficiently rapidenough (<50 msec) such that inadvertent motion of the handheld scanninghandpiece does not appreciably affect the pattern. The handheld scanninghandpiece can be repositioned to treat the next zone, and the opticaldetection of registration features at the correction positioning of thedressing with respect to the handpiece will again trigger the release ofa laser scan pattern.

Alternatively, a handpiece with either scanning patterns or fixedpatterns (including a single shot) can be manually positioned laterallyto the dressing, with optical detection of the registration features202, 204 triggering individual firing events. One example involves theuse of an optical mouse-type arrangement in which a light source such asan LED projects onto the dressing surface and the reflected or scatteredlight from the dressing is re-imaged into an optical detector as thehandheld device is manually moved laterally across the dressing.

Alternatively, a complete image may be acquired by an imaging system,and image-processing software may be used to create a custom scanpattern to be delivered. The positioning of the dressing with respect tothe laser delivery system, the particular configuration of the dressing,the desired pattern of lesions may all be processed to determine acustomized laser scanning pattern appropriate for a particular dressingand patient. In this realization, a relatively large area may be treatedby a scanned laser pattern, which may require a duration that is longenough that movements of the patient with respect to the laser deliverydevice may occur. The invention may interrupt delivery of laser pulsesis motion of the registration features 202, 204 is detected. Thepositioning may be restored and laser firing resumed. Alternatively, anew image may be acquired and a new laser delivery pattern computed anddelivered.

FIG. 12B provides a partial illustration of another variation of adressing 100. In this variation, a dressing 100 can include a surfacethat provides a particular optical or other identifiable property thatcan be recognized by the treatment device to alter treatment parametersor lesion location based upon pre-determined parameters. For example,the dressing 100 can include a particular, reflective, absorptive, orscattering characteristic that is recognized by the treatment device. Inaddition, as shown, a dressing can include a first region 206 having afirst set of characteristics, and a second region 208 having a secondset of characteristics.

FIGS. 13A to 13E show another variation of a dressing 100 covered by amask 128 where the dressing 100 and mask 128 allow for a treatmentdevice to create lesions at specific areas, thereby eliminating the needto align the dressing with the lesion. As shown, the mask 128 caninclude openings 129 that are in alignment with opening 108 in thedressing. Optionally, the mask 128 can apply strain to the dressing 100.FIG. 13A illustrates the dressing 100 in a strained configuration toplace the tissue 12 in a state of traction. The dressing 100 and mask128 are exposed to the treatment energy 120 (e.g, a laser or othertreatment modality). The therapeutic energy 120 creates ablationpatterns 14 and 131 in the tissue 12 and the mask 128 respectively. FIG.13C shows removal of the mask 128 and eventual compression/closure ofthe lesions 14 as the dressing 100 contracts. FIGS. 13D and 13Eillustrate top planer view of a dressing 100 and mask 128 havingrespective openings 108 and 129. FIG. 13D shows the dressing 100 andmask 128 pre-treatment. FIG. 13E shows the dressing 100 and mask 128after the ablation process. As shown, the ablation pattern 14 and 131can be created over a wider area than the opening 14 in the dressing 108but only forms lesions 14 in the tissue in a limited manner at theexposed areas.

FIG. 14A illustrates another advantage of creating a lesion 14 in situwith the dressing 100. As shown in FIG. 14A, the lesion 14 as well asthe opening 108 in the dressing 100 can be made to have a unique shapethat can be made or modified during the procedure. For example, FIG. 14Ashows a dressing 100 with a lesion 14 in tissue, where both the lesion14 and opening 108 are made to have a longer dimension when viewed along14C-14C (as shown in FIG. 14C), when compared to direction 14-B-14B (andas shown in FIG. 14D). Furthermore, the lesion pattern can be anon-linear design. An additional example of such patterns is shown inFIG. 14D

FIGS. 15A to 15D illustrate another use for dressings of the presentdisclosure.

FIG. 15A illustrates an array 190 of electrodes 192 adapted to penetratesubdermal tissue, such as subcutaneous layers 12. FIG. 15B illustrates adressing 100 as described herein, where the dressing is strained andplaced over the electrodes 192 as shown in FIG. 15B. The electrodes 192(e.g., RF electrodes or any other energy modality described herein)applies energy to the subcutaneous fat layer 12 to lyse, burn, orotherwise breakdown the fat to create a lesion 22 or cavity 22. FIG. 15Cillustrates removal of the electrode array 190 leaving the dressing 100in place against the dermal region 10 of tissue. Because the dressing100 is in a strained configuration, removal of the dressing 100 from theelectrode array causes movement of the dressing 100 to close theopenings 108 as described above.

FIG. 16 depicts an additional use of a dressing 100 as a mask to directcreation of the lesion 14. As illustrated, an electrode 142 or otherlesion creation element is placed against a dressing 100 such thatactivation of the element 142 creates lesions 14 through openings 108 inthe dressing 100. As discussed above, creating lesions 14 throughopenings 108 in the dressing 100 eliminates the need to match openingsin the dressing to lesions. The use of the dressing 100 as a mask typeelement eliminates the need for electrodes penetrating into tissue.

Elastomeric dressings of the present disclosure can also be used byaffixing to the tissue, stretching or straining once placed on tissue.Then creating the lesions in the tissue. The dressing can then bereleased to compress the lesion. The dressing can also be removed sothat the natural elasticity of the skin or tissue helps appose thelesion openings. Accordingly, the dressing can be removed.

In additional variations, the dressings or frames described herein canbe affixed to external structures placed on a patient to provide thedegree of lift or tissue movement required for an acceptable clinicaleffect. For example, a cap or similar structure can be placed on apatient's head and serve an anchoring type device that allows thedressings or frames to displace tissue for an acceptable simulatedvisual result.

The devices, methods and kits described herein can be used for applyingforce to any portion of tissue to compress, reposition, or lift tissueas required by the intended cosmetic application (e.g., lifting of thebreast, stretching scalp tissue to increase a density of implanted,underarm, abdominal procedures, etc. The dressing described herein canbe fabricated from any

biocompatible material that can provide the compressive force necessaryto achieve

the intended result. For example, the dressings can comprise a polymer,a shape memory polymer (e.g., acrylate-based, styrene-based andepoxy-based shape memory polymers), or biocompatible polymer (e.g.,silicone). The dressings and/or frame can be transparent or opaque orhave other features as required by the intended application. The strainrates of the dressings and frames described herein can range from 1% to100% either uni-directional, uni-axial, or bi-axial.

The fixation means described above can include any conventionally knownmeans to secure similar dressings or frames to tissue. For example, thedevices can be secured to tissue in a variety of ways (eithertemporarily affixed or affixed until the fixation means is removed). Forexample, the devices can be removably secured to the tissue with anadhesive, with a skin piercing device, or the like. Suitable adhesivesinclude pressure sensitive adhesives, such as polyacrylatebased,polyisobutylene-based, temperature activated adhesives, chemicallyactivated adhesives and silicone-based pressure sensitive adhesives.Suitable skin-piercing devices include clamps, needles, microneedles,sutures, anchors, staples, microtines and the like.

The devices may have any suitable or desirable shape or size. In someexamples, the shape of the dressings or frames can be adjusted before,during or after the procedure. For example, the devices may have a shapeselected from the group consisting of rectangles, circles, squares,trapezoids, toroids, ovals, or segments and combinations thereof. Forexample, some devices may be substantially circular, others may besubstantially toroidal, and still others may be substantiallyrectangular.

In another aspect, altering the geometry of a lesion to assist in woundhealing can be combined with methods and devices described herein toimprove the outcome of a treatment. For example, FIG. 17A provides arepresentative illustration of a top view of a lesion 14 withoutapplication of any compressive force. FIG. 17B illustrates the lesion 14of FIG. 17A, where a compressive force, as described above andillustrated by arrows 26, attempts to close the lesion 14. However, thelesions 14 circular geometry creates regions of increased stress 28. Thehigh stress regions 28 are not desirable for a number of reasons. Forexample, the high stress regions 28 can impede the healing process.Moreover, the high stress regions 28 caused increased resistance whenattempting to close the lesion 14. For example, the high stress regions28 can provide an opposing force to the dressing and ultimately renderthe procedure less effective. FIG. 18A shows a variation of a shapedlesion 30 intended to reduce areas of high stress when the lesion 30 iscompressed as discussed herein. The lesion 30 can be created via asingle treatment or can comprise a number of treatments to produce adesired shape. For example, in FIG. 18A the lesion 30 can be created tobe asymmetrical so that portions 32 of the lesion 30 do not generatehigh areas of stress when the lesion is compressed (see e.g., FIG. 18B).In one example, a shaped lesion 30 is created via a slit in tissue andsuperimposing a circular lesion on the slit portion. Alternatively, asshown in FIG. 18C, a standard lesion 14 is created and then a secondaryprocess creates one or more additional lesions 32 to create a shapedlesion 30 as shown in FIG. 18D. The creation of the base lesion 14 canbe made by any conventional means (e.g. a CO₂ laser) that creates alesion of the desired size. The additional lesions 32 can be createdusing a means that allows creation of smaller lesions.

FIG. 18E illustrates another variation of a lesion 14 with features 32to prevent high stress areas upon compression of the tissue. Suchcomplex lesions can be created using a masking approach or creatingseries of therapeutic treatment lesions similar to that shown in FIG.18D. FIG. 18F illustrates another lesion geometry conducive to avoidinghigh stress areas upon compression of tissue. In this variation, thelesion 14 includes a relatively simple geometric configuration (oval asopposed to circular).

The applications of the disclosed invention discussed above are notlimited to certain treatments or regions of the body, but may includeany number of other treatments and areas of the body. Modification ofthe above-described methods and devices for carrying out the invention,and variations of aspects of the invention that are obvious to those ofskill in the arts are intended to be within the scope of thisdisclosure. Moreover, various combinations of aspects between examplesare also contemplated and are considered to be within the scope of thisdisclosure as well.

1. A skin treatment device.